Assessment of Medicine Quality Assurance in Rwanda:

Overview of Findings and Recommendations for Consideration

Kigali and Butare, Rwanda

November 9-13, 2009

Trip Report

Mustapha Hajjou, Ph.D., PQM

Abdelkrim Smine, Ph.D., PQM
Veerle Coignez, MA, MPH, USAID

Promoting the Quality of Medicines Program

Implemented by U.S. Pharmacopeia
12601 Twinbrook Parkway
Rockville, MD 20852 USA
Tel: (+1) 301-816-8162
Fax: (+1) 301-816-8374
Email: pqm@usp.org

Cooperative Agreement # GHS-A-00-09-00003-00

Sponsoring USAID Mission: USAID/Rwanda
Grantee: Promoting the Quality of Medicines (PQM) Program
Author(s) Name: PQM Staff
Language: English
Date of Publication: December 23, 2009

This report is made possible by the generous support of the American people through the
United States Agency for International Development (USAID), under Cooperative
Agreement No. GHS-A-00-09-00003-00 (and the Presidents Malaria Initiative). The
contents are the responsibility of the Promoting the Quality of Medicines Program,
implemented by the U. S. Pharmacopeia, and do not necessarily reflect the views of
USAID or the United States Government.
 Assessment of Medicine Quality Assurance in Rwanda: Findings and Recommendations
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About PQM
The Promoting the Quality of Medicines (PQM) program, funded by the U.S. Agency for
International Development (USAID), is the successor of the Drug Quality and Information (DQI)
program implemented by the United States Pharmacopeia (USP). PQM is USAIDs response to
the growing challenge posed by the proliferation of counterfeit and substandard medicines. By
providing technical assistance to developing countries, PQM helps build local capacity in
medicine quality assurance systems, increase the supply of quality medicines to priority USAID
health programs, and ensure the quality and safety of medicines globally. This document does
not necessarily represent the views or opinions of USAID or the United States Government. It
may be reproduced if credit is given to PQM and USP.

Abstract
PQM conducted an assessment of the medicine quality assurance and quality control systems in
Rwanda during November 9-13, 2009. Medicine quality assurance remains to be developed in
Rwanda: the country has neither a medicine regulatory authority (MRA) nor a national medicine
quality control laboratory the two key institutions to ensure the quality, safety, and efficacy of
medicines. The MOH Pharmacy Taskforce (PTF) is to be commended however for successfully
controlling the pharmaceutical market to the extent that there is no informal medicines market in
Rwanda. Based on its findings, the assessment team expects Rwanda to be able to make great
strides in evidence-based medicines quality assurance in the short to medium term, provided it
receives adequate technical assistance and financial support.

Recommended Citation
Coignez, V., Hajjou, M., and Smine, A. 2009. Assessment of Medicines Quality Assurance in
Rwanda: Overview of Findings and Recommendations for Consideration. Rockville, Maryland
USA; December 8, 2009. Submitted to the U.S. Agency for International Development by the
Promoting the Quality of Medicines Program. Rockville, Maryland: United States Pharmacopeia.

Key Words
Rwanda, assessment, medicines quality assurance, quality control, medicine regulatory authority

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Table of Contents

Acknowledgements...................................................................................................... 3
Acronyms ...................................................................................................................... 4
Background .................................................................................................................. 5
Purpose of Trip ............................................................................................................. 5
Executive Summary ..................................................................................................... 6
Overview of Regulatory and Institutional Context for QA in Rwanda .................... 8
Key Institutions ................................................................................................. 8
Legal and Regulatory Framework .................................................................. 10
Overview of Assessment Team Meetings and Activities ........................................ 10
Recommendations on Next Steps ........................................................................... 14
Annex 1: PowerPoint Presentation ........................................................................... 16
Annex 2: Relevant Information for Developing Sampling Strategy ....................... 19

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ACKNOWLEDGEMENTS

The PQM team would like to acknowledge the Ministry of Health staff in Rwanda for their
support and participation, particularly:
Dr. Corine Karema, Director, Programme National Intgr de Lutte contre le Paludisme
(PLINP);
Ms. Monique Murindahabi, Deputy Director, PNILP;
Mr. John Patrick Mwesigye, Coordinator, Pharmacy Task Force; and,
All other local partners who met with us during this assessment.

The PQM team would also like to express their great appreciation to:

Dr. Annett Cotte for the planning and coordination of the assessment.
Dr. Roopal Patel for coordinating all the meetings and for her valuable assistance and
advice during the visit.
Dr. Christopher Talley for his enthusiastic support.
The PQM administrative staff and editors for their assistance with logistical arrangements
and for editing the trip report.
Mr. Anthony Boni and Ms. Veerle Coignez at USAID/Washington for their continued
support.

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ACRONYMS

AIDS Acquired Immunodeficiency Syndrome

BUFMAR Bureau des Formations Mdicales Agres du Rwanda
Central dAchat des Mdicaments Essentiels,
CAMERWA
Consommables et Equipements Mdicaux du Rwanda
DQI Drug Quality and Information Program
GMP Good Manufacturing Practices
HIV Human Immunodeficiency Virus
Laboratoire dAnalyse de Denres Alimentaires et des
LADAMED
Mdicaments
MOH Ministry of Health
MOP FY09 Malaria Operational Plan, Fiscal Year 2009
QA Medicine quality assurance
QC Medicine quality control
QCL Medicines Quality Control Laboratory
MSH Management Sciences for Health
NUR National University of Rwanda
PEPFAR President's Emergency Plan for AIDS Relief
PMI Presidents Malaria Initiative
PNILP Programme National Intgr de Lutte contre le Paludisme
PQM Promoting the Quality of Medicines Program
PTF Pharmacy Task Force
QA Quality Assurance
QC Quality Control
RBS Rwanda Bureau of Standards
RFDA Rwanda Food and Drug Administration
USAID United States Agency for International Development
USP United States Pharmacopeia
USP-NF United States Pharmacopeia National Formulary
WHO World Health Organization

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Background
With a land area of 9,633 sq mi and a population of more than 10 million, Rwanda is one of the
most densely populated countries in Africa. In 2003, the total expenditure on health was 3.7% of
the gross domestic product. The private expenditure was 56.5% of the total expenditure on
health.

In 2006, Rwanda was selected as one of the 15 countries to benefit from the Presidents Malaria
Initiative (PMI), in collaboration with the United States Agency for International Development
(USAID). Recent data have shown a dramatic decrease in malaria incidence and child mortality,
and malaria is no longer the leading cause of morbidity and mortality in Rwanda. However, the
whole population remains at risk.

Because of the reported increase in the number of substandard and counterfeit medicines, PMI
has decided to support strengthening the medicine quality control system in order to detect and
monitor the quality of antimalarial medicines available on the Rwandan market (Source: FY09
MOP).

On this trip, Dr. Mustapha Hajjou, Ms. Veerle Coignez, and Dr. Abdelkrim Smine conducted an
assessment of the medicine quality assurance and quality control (QA/QC) systems in Rwanda.

Purpose of Trip
Conduct an assessment of the pharmaceutical sector in Rwanda;
Meet with the teams from USAID, PMI, and the Presidents Emergency Plan for AIDS
Relief (PEPFAR).
Meet with staff from the Rwandan Malaria Control Program and other key partners; and,
Recommend priority activities to strengthen antimalarial medicine quality control in
Rwanda.

Source of Funding
This trip was supported with funds from USAID/Rwanda under PMI.

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Executive Summary

Medicine quality assurance (QA) in the Rwandan pharmaceutical sector remains to be

developed. The country currently lacks two key institutional pillarsa Medicines Regulatory
Authority (MRA) and a minimally functioning Medicine Quality Control Laboratory (QCL)to
ensure the quality, safety, and efficacy of medicines in the country.

That being said, the PQM assessment team fully commends the Ministry of Health (MOH)
Pharmacy Taskforce (PTF) for the control it currently exercises over the pharmaceutical sector
through the documentation requirements imposed for registration of medicines, and through the
licensing and inspection of pharmaceutical establishments. The assessment team was most
impressed that (1) the PTF, with the support of the Rwanda Bureau of Standards (RBS), has
control over the medicines that enter Rwanda; (2) the pharmaceutical establishments appear to be
compliant with relevant Ministerial Decrees, primarily due to PTF inspections and demonstrated
readiness by the MOH to close down establishments that do not comply; and (3) there is no
informal market for medicines.

The MOH, the PTF, and the Central Medicine Store (CAMERWA) have taken QA as far as they
possibly can, based on administrative documentation review. However, because there is no
technical evaluation of medicine dossiers during registration and no access to quality testing of
medicines within the country, the quality, safety, and efficacy of medicines in Rwanda currently
remain unchecked and, thus, not assured.

The Rwandan stakeholders, including the Malaria Control Program (called PNILP in Rwanda),
are already fully cognizant of the need to establish an MRA with access to medicine quality
control capability.

The PQM assessment team recommends that the PNILP consider taking the following measures
with the funds available from PMI/USP to support strengthening the QA/QC in Rwanda in the
coming year:

Build QC capability at the University of Rwanda by:

Repairing and servicing equipment;
Providing the necessary reagents, references standards and basic lab supplies; and,
Training the staff in sampling and testing of antimalarials at the national and district
levels. There is no need to introduce Minilabs at this point.
Provide technical support to the development of a post-graduate curriculum in QA/QC.

In the medium to long term, after an MRA is effectively established, the PNILP, other Rwandan
stakeholders, and donors may consider supporting the following measures in order to further
strengthen QA in Rwanda:
Develop the MRAs capacity to conduct medicine registration through technical
evaluation of the quality, safety, and efficacy of the medicines;

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Provide continued targeted support to speed up the strengthening of QC lab at the

National University of Rwanda (NUR) as a QA/QC nucleus
Expand the QA/QC nucleus into a full-fledged MQCL in Kigali;
Develop a post-marketing surveillance strategy and system to monitor the quality of
medicines, as the necessary complement to the pharmacovigilance activities;
Provide support to the NUR Pharmacy Department to train pharmacists in QA. This will
provide the potential technical human resources needed to staff and establish a regulatory
authority and QC lab.

Based on its findings from the assessment, the assessment team has little doubt that, with the
necessary technical assistance and financial support, Rwanda will be able to make great strides in
introducing evidence-based QA, including medicines quality control (QC), in the short to
medium term.

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Overview of Regulatory and Institutional Medicines QA Context in Rwanda

This section provides an integrated overview of the medicines quality assurance context in
Rwanda. The overview is based on information compiled from a variety of documents,
including the PMI FY09 Malaria Operating Plan (MOP) for Rwanda and the Ministry of
Healths 2008 Annual Report, as well as from many interviews, meetings, and site visits
undertaken during this assessment. A chronological overview of the meetings and site visits,
with selected highlights, is presented in the next section.

o Key Institutions

The MOH currently relies on the MOH Pharmacy Taskforce (PTF), in essence an MOH
department, to develop pharmaceutical policy and to fill the role of a full-fledged Medicines
Regulatory Authority to ensure the quality, safety, and efficacy of medicines. The PTF consists
of three main departments: (1) Drug Registration; (2) Pharmacist Inspectors; and (3) Rational
Use. The PTF is, by all reports, in control of the medicines on the Rwandan market. There was
near unanimity among all counterparts interviewed that, basically, nothing gets on the market
without PTF registration, except perhaps in the regions bordering neighboring countries. It was
not possible for the PQM team to verify to what extent this assertion is correct during the
assessment. However, it will be possible to obtain evidence in this regard once implementation
starts of the proposed activity to sample and test antimalarial medicines on the market (aka post-
marketing surveillance). For example, PQM-supported post-marketing surveillance in another
African country have documented the presence of non-registered medicines on the market and
have provided the necessary evidence base for the national regulatory authority to take targeted
corrective action.

The registration procedure is entirely document-based; there is neither the technical capacity nor
the necessary human resources for technical evaluation of a dossier. The document requirements
for visas, authorization of importation, and registration include: (1) documentation of
manufacture, wholesale, and export licenses; (2) certification of Good Manufacturing Practices;
and (3) product-specific information. In the words of one of the counterparts interviewed,
Rwanda is at the mercy of donors and suppliers for quality control of medicines.

The PTF has an inspection team comprised of four inspectors who primarily examine private-
sector establishments. The inspectors verify compliance with administrative requirements, as
spelled out in the relevant Ministerial Decrees. Only a few samples have been sent to laboratories
outside the country for QC analysis.

The MOH has the reputation for closing down any pharmaceutical establishment that does not
comply with requirements. Throughout these visits, pharmaceutical establishments showed
respect for and compliance with MOH regulations and norms. That said, during a visit to a
pharmacy in Butare, members of the assessment team were able to buy Coartem for adults for
the price of 2,000 francs. (The product was not displayed; the woman disappeared behind a
curtain to get the product, which presumably was taken from a public health facility).

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The Rwandan Board of Standards is involved in checking whether the imported and donated
medicines meet the documentary standards upon entry to the country. Most medicines arrive by
air; however, there is a dry port to which medicines that arrive over land are directed. The RBS
has inspectors posted at the airport and now also sends three inspectors to crossings at the
Western border (to deal with medicines coming from the DRC). An RBS pharmacist guides the
inspectors. The PBS batch certification is based on document review; there is no visual
inspection of packages nor quality control testing at the laboratory.

There is no medicines quality control laboratory in Rwanda capable of conducting the full
spectrum of basic tests to determine the quality of the medicines. The National University of
Rwanda (NUR) in Butare does have a basic lab facility that has the potential to become a basic
medicine quality control testing lab: i.e. the lab of the NUR Pharmacy Department, LADAMED.
The main findings of the site visit to the Lab are presented in the next section (pp 12-13).

As stated in MOP FY09, the Central Medicine Store or CAMERWA functions as the MOHs
procurement arm and national medical store for Rwanda, procuring about 60% of public health
facility medicines and supplies.

CAMERWA uses a document-based system to ensure, to the extent possible, the quality of the
medicines procured. For program-donated medicines (including Global Fund, Clinton
Foundation, PEPFAR, PMI, or HIV/AIDS, TB and malaria medicines), the products are pre-
qualified either by the World Health Organization (WHO) or CAMERWA itself. Quality
concerns focus on the essential medicines, which are procured through international bids.
CAMERWA does pre-qualify suppliers based on documentation review (for a three-year period,
at the moment). A GMP certificate and certificate of analysis are requested, but the agency is not
always certain whether or not the documents are genuine. In addition to document reviews,
CAMERWA sends some samples (about 50 samples, twice a year) for quality control testing by
labs in Belgium, France, and South Africa, but the process is expensive and the results are not
always timely. The sampling focuses on new products from new suppliers or on products that
look suspicious upon visual inspection. CAMERWA stopped working with one supplier in
recent years because of quality concerns.

CAMERWA has a central warehouse in Kigali, which is being refurbished, with donor support.
A visit to the CAMERWA warehouse revealed that there is room for further improvement in
terms of storage practices (for more details, see section below, p.11).

A secondary procurement agency is BUFMAR, which was set up by faith-based organizations.

If a product is not available at CAMERWA, public health facilities can try to procure it from
BUFMAR, using the private sector as a third and last resort. The procurement and QA capacity
of BUFMAR is quite limited compared to CAMERWA. BUFMAR also uses document reviews
for QA purposes; it does not do any sampling or testing. The BUFMAR President claimed not to
have had any quality problems over the last twothree years under his tenure.

There is one public sector manufacturer, LABOPHAR, that produces some essential medicines,
including antibiotics, but their quality control is reportedly not up to international standards. A
WHO consultant reportedly concluded a few years ago that the facility should be closed.

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[Source: the former President of the Pharmacists Association]. The assessment team did not have
an opportunity to visit the manufacturing site during this assessment.

o Legal and Regulatory Framework

Currently, there are two key laws dating back to 1998 and 1999 that frame pharmaceutical policy
in Rwanda: (1) Law No. 10/98 establishing the practice of the art of healing; and, (2) Law No.
12/99 relating to pharmaceutical arts.

In addition, there are a number of Ministerial Decrees that are relevant to medicines quality
assurance. They focus mostly on regulating pharmaceutical establishments in the private sector:
(1) defining pharmaceutical establishments; (2) establishing conditions for wholesale pharmacy;
(3) establishing conditions for retail pharmacy; (4) introducing a limited list of medicines that
can be sold at pharmacies; and, (5) outlining the practice of inspection of pharmaceutical
establishments.

A process is underway to set up a full-fledged Medicines Regulatory Authority. Law No. 12/99
will be replaced by a new law that establishes a Rwandan Food and Drug Administration
(RFDA) whose functions will be outlined in an accompanying law. The expectation is that the
RFDA will be established sometime in 2010 and that it will ultimately regulate food, medicines,
poisons, herbal medicines, cosmetics, health products and medical devices.

In conclusion: The MOH, the PTF, and CAMERWA have taken QA as far as they possibly can
on the basis of administrative documentation review. However, because there is no technical
evaluation of medicine dossiers during registration and no access to quality testing of medicines
within the country, the quality, safety, and efficacy of medicines in Rwanda ultimately remain
unchecked currently and, thus, not assured. The current process to review existing legislation and
establish a MRA provides a window of opportunity to start strengthening medicines quality
assurance in the country.

Overview of Assessment Team Meetings and Activities

Meeting with USAID/PMI, PNILP, and PTF Monday, Nov. 9

Counterparts: Monique Murindahabi, (PNILP Deputy Director); Dr. Roopal Patel (PMI
advisor for U.S. Centers for Disease Control (CDC)); Dr. Patrick Condo (USAID-PMI
advisor)
Discussion: The PQM team reviewed the schedule of meetings and site visits with Dr.
Roopal and gave a quick overview on how the assessment would be conducted. It was
agreed that the assessment would be general in nature and not focus narrowly on
antimalarial medicine quality alone.

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Meeting with National University of Rwanda (NUR), Pharmacy Department Monday,

Nov. 9
Counterparts: Prof. Pierre Claver Kayumba (Senior Lecturer, Pharmacy Dept, NUR)
Discussion: Prof. Claver reported that the QC Lab at NUR leaves much to be desired in
terms of space, equipment, reagents and reference standards, and technical capacity. We
briefly discussed the merits of developing a QC Lab in Butare vs. Kigali. There was also
discussion about the possibility of PQM providing assistance in supporting sourcing of
QC/QA materials for courses and/or relevant information for proposal writing. The NUR
Pharmacy Department would appreciate receiving the current U.S. Pharmacopeia-
National Formulary (USP-NF), reference standards, and training materials.

Meeting with CAMERWA -- Tuesday, Nov. 10

Counterparts: Ambassador Zephyr Mutanguha (Director General); the Deputy Director
General; Immacule Mukankubito (Head of Quality Assurance); the Warehouse Director;
Christopher Talley (USAID, Health Commodity and Logistics Advisor); Caroline Healey
(Supply Chain Management System (SCMS) Country Director); and Geoffrey Ngwira
(SCMS Procurement Advisor).
The team visited the CAMERWA warehouse. CAMERWA does not yet fully comply
with good storage practices for example, there is no temperature and humidity
monitoring, no temperature mapping of the warehouse, numerous broken windows
(would allow birds and insects to enter the warehouse), no apparent pest control, a door
wide open to the outside environment, and poor storage and labeling.
SCMS had provided CAMERWA with a computerized system for stock management of
medicines, but the paper-based system is still active during this transition period.

Meeting with BUFMAR -- Tuesday, Nov. 10

Counterparts: Ernest Rwagasana (Director); and Nathalie Furere (Pharmacist and
warehouse manager)
The meeting included a quick visit to its production facility for ointments and
suppositories and to its warehouse. The assessment team found that the small
manufacturing facility does not comply with good manufacturing practices (GMP). All
manufacturing machines are used in complete open spaces with no respect to GMP,
despite the fact that the products being manufactured are external skin preparations.

Meeting with Strengthening Pharmaceutical Systems (SPS) Tuesday, Nov. 10

Counterparts: Ins Buki Gege (Senior Technical Advisor); Felix Hitayezu (Senior
Program Associate); Patrick Gaparayi; Aline Mukerabirori; and Denise Murekatete
Discussion: SPS staff provided a useful overview of the pharmaceutical sector and SPS
program work in Rwanda.

Meeting with the Pharmacy Task Force -- Tuesday, Nov. 10

Counterparts: John Patrick Mwesigye (PTF Coordinator) and colleagues
Discussion: The PTF is not an MRA, but it does have control of the pharmaceutical
sector; together with the Rwanda Bureau of Standards, it carries out inspections and
documentation-based control of medicines when they reach the port of entry. The PTF
registers medicines based on paper review, and selects and tracks suppliers. According to

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the PTF, Rwanda is at the mercy of donors and suppliers with regard to the quality of
medicines. Some samples have been sent through the inspection team to Belgium,
Nairobi, and South Africa. PTF also explained the ongoing process to revise
pharmaceutical legislation. PQM offered to forward to PTF the draft legislation PQM and
USAID helped draft and negotiate in Liberia.

Meeting with PSI Wednesday, Nov. 11

Counterparts: Staci Leuschner (PSI Country Representative); and PSI program manager
PSI facilitated a visit to two wholesalers and two pharmacies in Kigali.
Part of the meeting focused on the different levels of the public and private distribution
systems. PSI confirmed there are about 40 private wholesalers and 46 private pharmacies
in Rwanda, most of them in Kigali. The comptoires pharmaceutiques or
pharmaceutical shops are allowed to carry a limited type of essential medicines, including
a subsidized artemisinin-based combination therapy (ACT) named Primo for infants and
children that are sold for 300 Francs per regimen. There was a brief discussion about the
possibility of leakage from the public sector and a possibility of adults using double
doses of subsidized ACTs.

Meeting with Rwandan Bureau of Standards Wednesday, Nov. 11

Counterpart: Jane Nyamvumba (Director of Quality Assurance Unit, RBS)
Discussion: Ms. Nyamvumba provided an overview how the RBS assists the PTF in
checking documentation requirements for medicines arriving in-country by air or land.
RBS aims to train MOH staff so that all inspections will be carried out by MOH.
RBS carries out some QC for food samples.
The PQM team did not have an opportunity to visit the RBS laboratory facilities.
Ms. Nyamvumba did state that the RBS has sufficient facility space to house a medicines
quality control lab.

Site Visit to Medicine Quality Control Laboratory Site, National University of Rwanda,
Butare (LADAMED)
Counterparts: Prof. Justin Kadima (Head of Pharmacy Dept.); Prof. Pierre Claver
Kayumba (Senior Lecturer, Pharmacy Dept.); LADAMED staff; Antoine Gatera
(SCMS); Felix Hitayezu (SPS); and Patrick (PTF).

Overall Situation
The Laboratoire de Denrees Alimentaires et
Medicaments (LADAMED) is the laboratory
of the NUR Department of Pharmacy. It was
partially established with support and funds
from the University of Liege in Belgium.
It is the only facility with quality control
capability in Rwanda. It consists of three
unitsmicrobiology, food and medicines
QCeach of which has a supervisor who is
faculty member. All LADAMED activities are LADAMED laboratory in Butare
coordinated by one faculty staff member. In

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total, there are seven analysts dedicated to working in different units of the QC lab.
The availability of both a physical entity and full-time dedicated staff make it possible to
begin developing a medicines quality control capacity in Rwanda. The staff, the know-
how, and the resources available at this lab could be strengthened sufficiently to
constitute a nucleus for establishing a national MCQL at a later time.
It is also worth noting that the lab receives regular requests from both public and private
clients for quality testing of medicine samples. The reported requests come from both the
public and private sector. LADAMED has had to turn down the requests due to lack of
resources until now, but if strengthened, QC testing for both the public and private sector
may ultimately represent an important income source for the lab.

Needs
The rooms in the lab are small and inadequately aerated, but the lab could be used as an
interim facility for QC until a full-fledged QC lab can be built.
The lab has a new HPLC (Agilent technologies HP1200), but the majority of the lab
equipment is not functional (HPLC, Dissolution tester, GC with Head space, Water
deionizer, etc.).
Additional basic equipment is greatly needed, including a UV spectrophotometer, IR, thin
layer chromatography (TLC) apparatuses, and water filtration system.
The lack of chemical reagents is one of the major handicaps in this lab. Most of the
existing chemicals have expired. The lab needs the basic reagents to carry out basic
medicine QC.
The lab analysts and supervisors need training on quality control of medicines and in
good laboratory practices.

Capacity Building Program

The NUR Pharmacy Department is well advanced in planning a one-year postgraduate
diploma for graduate pharmacists to specialize in QA/QC. The Chairman of the
Department asked for PQMs support for developing training modules and training in
theoretical practical courses in various topics about medicines QA. The program is
scheduled to start next year by training 15 pharmacists.
This proposed program merits technical and financial support in the opinion of the
assessment team because it will provide the human resources and technical capacity
needed to staff and establish a regulatory authority and QC lab.

Visits to Wholesalers, Private Pharmacies, and Public Pharmacies in Kigali and Butare
Wednesday-Thursday, Nov. 11-12
The assessment team visited two private pharmacies and two private wholesalers in
Kigali, and one comptoir pharmaceutique in Butare.
All the facilities that were visited appeared to be very well maintained.
Discussion: According to one pharmacist, a former president of the Pharmacists
Association, there are too many wholesalers in Rwanda that do not merit the designation
of wholesaler: they carry only a few medicines. He believes, in this regard, there is lack
of regulatory clarity.

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Debriefing at the Center for Treatment and Research on AIDS, Malaria, Tuberculosis and
Other Epidemics Friday, Nov. 13
Counterparts: Dr. Corine Karema (Director, National Malaria Program); Dr. Wayne Stinson
(USAID Malaria Advisor); and Monique Murindahabi (PNILP Deputy Director)
The PQM team provided an overview of the assessment, reported the major findings, and
outlined proposed activities for PNILP consideration.
The Power Point presentation of the main findings and recommendations is attached
(Annex 1).

Recommendations on Next Steps

The Rwandan stakeholders, including the Malaria Control Program (PNILP), are already fully
cognizant of the need to establish an MRA with access to medicines quality control capability.

In this context, and on the basis of available funding, PQM recommends the PNILP consider
taking the following measures to support strengthening QA/QC in Rwanda in the coming year:

Build QC capability at the University of Rwanda by:

Repairing and servicing equipment;
Providing the necessary reagents, references standards and basic lab supplies; and,
Training the staff in sampling and testing of antimalarials at the national and district
levels. The training will focus on two key analytical methods. PQM will assist in the
actual conducting of key quality tests to allow for immediate feedback and
reinforcement. Relevant information to guide sampling is presented in Annex 2.
There is no need to introduce Minilabs at this point.

If limited additional funding can be made available, PQM strongly recommends providing
technical support to the development of a postgraduate curriculum in QA/QC. As stated, this
capacity building program merits full support because it will provide the human resources and
technical capacity needed to staff and establish a regulatory authority and QC lab.

In the medium to long term, and after an MRA is effectively established, the PNILP, other
Rwandan stakeholders, and donors may consider supporting the following measures in order to
further strengthen QA in Rwanda:
Develop the MRAs capacity to conduct medicine registration through technical
evaluation of the quality, safety, and efficacy of the medicines;
Provide continued targeted support to speed up the strengthening of QC lab at the
National University of Rwanda (NUR) as a QA/QC nucleus
Expand the QA/QC nucleus into a full-fledged MQCL in Kigali;
Develop a post-marketing surveillance strategy and system to monitor the quality of
medicines, as the necessary complement to the pharmacovigilance activities;

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Provide support to the NUR Pharmacy Department to train pharmacists in QA. This will
provide the potential technical human resources needed to staff and establish a regulatory
authority and QC lab.

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 Assessment of Medicine Quality Assurance in Rwanda: Findings and Recommendations
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Annex 1

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Annex 2

Relevant Information for Developing Sampling Strategy

Rwanda in General
Rwanda is approximately the size of the State of Maryland. The population is approximately
10 million, approximately 1 million of whom live in Kigali. It is one of the most densely
populated countries in the world.
There are 30 administrative districts.

The Rwandan Health Care and Pharmaceutical Sectors

Public Health Care Sector: There are four national reference hospitals, some 40 district
hospitals, and approximately 450 public and faith-based health centers.
There also exists an extensive network of some 60,000 community health workers. They are
the backbone of home-based healthcare management that has been formed to complement
and extend the primary health care system.
Private Health Care Sector: There are approximately 200 private clinics.
Pharmaceutical Sector: CAMERWA and BUFMAR function as procurement arms of the
public and faith-based organizations. There are approximately 40 private wholesalers (the
large majority based in Kigali); 40 private pharmacies (offices, also mostly based in Kigali);
and approximately 200 comptoirs (medical stores with a limited list of medicines, mostly
outside the capital).

Treatment Policy
Since 2006, monotherapies have been banned for first-line treatment of uncomplicated
malaria. The standard treatment consists of Artemisinin-based combination therapies (ACTs)
are used, specifically artemether-lumefantrine (Coartem).
The second line treatment for uncomplicated malaria is quinine tablets.
Quinine and artemether are used for severe/complicated malaria. (According to some
sources, only in injectable form; according to Dr. Monique, both in injectable form and as
tablets).
SP treatment for IPTp has been discontinued.

Distribution of Antimalarials
Procurement: CAMERWA can legally import ACTs according to most sources/documents
while PSI reported it thought selected private sector wholesalers could also import ACTs.
There is no similar import restriction on other antimalarials.
Quality Assurance: All antimalarials are WHO pre-qualified.
Distribution Chain: There is nationwide distribution of ACTs through the public sector, the
faith-based organizations, and the community-based health workers who seek their supplies
from the health facilities they are affiliated with. The MOH also distributes through the
private sector treatments for uncomplicated malaria in children under five years old. (PSI
sells Primo products to the pharmaceutical depots only.)

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